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Perceived Barriers to Clinical Trials Participation: A Survey of Pediatric Caregivers
Natalie Sollo1, Carolyn R Ahlers-Schmidt1, Ann M Davis2
1Department of Pediatrics, University of Kansas School of Medicine-Wichita, Wichita, KS.
Insights
Caregiver trust in physicians and perceived benefits are key to enrolling children in clinical trials. Educating physicians to offer trials locally and providing incentives can increase pediatric participation.
Area of Science:
- Pediatric clinical trials
- Health services research
- Caregiver attitudes
Background:
- Pediatric clinical trials are crucial for ensuring safe and effective therapies for children.
- Off-label medication use in children is common due to a lack of pediatric-specific trial data.
- Children require appropriately tested therapies tailored to their unique physiological needs.
Purpose of the Study:
- To evaluate pediatric caregivers' beliefs regarding clinical trial participation.
- To identify perceived barriers that hinder caregiver involvement in pediatric clinical trials.
Main Methods:
- A cross-sectional survey was conducted within the Sunflower Pediatric Clinical Trials Research Extension (SPeCTRE).
- The survey adapted the Pediatric Research Participation Questionnaire and was administered to caregivers in a rural Midwestern state (2017-2018).
- A convenience sample of 159 pediatric caregivers completed the survey.
Main Results:
- Most caregivers (72.3%) were familiar with clinical trials, but few (20%) had been invited to participate.
- Physician trust significantly influenced willingness to enroll a child (p=0.04).
- Perceived benefits, including access to uninsured treatments and compensation for time/travel, correlated with participation willingness (p<0.01).
Conclusions:
- Physician trust is a primary factor in caregiver consent for pediatric clinical trials.
- Training physicians to offer trials locally is essential for increasing participation.
- Clinical trials must offer tangible benefits, such as access to care and compensation, to encourage enrollment.
Introduction:
Pediatric clinical trials are difficult to conduct, leading to off-label use of medication in children based on results of trials with adults. As a unique population, children deserve to have appropriately tested therapies. The purpose of this study was to evaluate pediatric caregivers' beliefs and perceived barriers to participation in clinical trials.
Methods:
The study was completed within the Sunflower Pediatric Clinical Trials Research Extension (SPeCTRE), an affiliate of the IDeA States Pediatric Clinical Trials Network (ISPCTN). This was a cross-sectional survey, adapted from the Pediatric Research Participation Questionnaire. A convenience sample of pediatric caregivers was recruited in three areas of a highly rural Midwestern state between 2017 and 2018.
Results:
A total of 159 caregivers completed surveys; the majority (72.3%) were previously familiar with clinical trials, but less than 20% had ever been invited to participate. Caregivers were willing to consider enrolling their child if a physician in whom they had high trust recommended the trials (H = 10.1, p = 0.04) and if there were perceived benefits, such as access to tests and medications not covered by insurance (correlation coefficient [CC] = 0.4, p < 0.01) and compensation for time and travel (CC = 0.3, p = 0.04).
Conclusions:
Trust in their physician highly influences likelihood of a caregiver consenting to have their child participate in a clinical trial. Therefore, to facilitate opportunities for children to participate in clinical trials, physicians need to be trained so they can offer trials locally. In addition, trials need to offer benefits, such as increased access to tests and medications as well as appropriate compensation.
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